Diabetes Mellitus Clinical Trial
— CIRCLEOfficial title:
Community Intervention to impRove CVD Risk Factor controL in Young AmErican Indians: The CIRCLE Study
American Indians are more likely to die from heart disease compared to other people in the United States. High levels of fat (lipids) and sugar (glucose) in the blood are related to heart disease. Young American Indians who are 15 to 39 years old have high lipid and glucose levels. This has led to heart disease later in life. This means they are likely to benefit from a program to lower these levels. In this project, researchers will work with American Indians in rural southwestern Oklahoma. The researchers will start by asking American Indians how they would like to design a program for younger members of their community. After getting permission, the researchers will take a small amount of blood from young community members. The researchers will measure lipid and glucose levels and ask those with high levels to be in the study. Then the researchers will do several measurements. These will include blood pressure, height, weight, diet, physical activity, tobacco and alcohol use, access to health care, and social support. The researchers will compare these measurements to similar measurements taken from young American Indians 20 years ago, collected through the Strong Heart Study, which is the longest running study measuring heart disease in American Indians. Next, the researchers want to know if the program they developed with the American Indian communities will work. To do this, they will put people in one of two groups. They will decide which group each person will be in using a process that is like flipping a coin (heads for one group, tails for the other group). One group will receive educational booklets about how to avoid getting heart disease. The other group will receive help from a community health worker. The community health worker will help participants to get to the doctor for treatment. They will also help participants change their diet and exercise routines and provide education about heart disease risk factors. After 9 and 18 months, the researchers will repeat the measurements to see if one of the groups has lower lipid or glucose levels. This program will support the National Heart, Lung, and Blood Institute's mission to "reduce human disease" by lowering lipid and glucose levels, which are related to getting heart disease. This will be done by using the community health worker model to help people go to the doctor and improve their lifestyle related to diet and exercise. The researchers will also be able to advance heart health in American Indians in rural Oklahoma by lowering factors related to heart disease.
Status | Not yet recruiting |
Enrollment | 330 |
Est. completion date | September 2029 |
Est. primary completion date | March 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 39 Years |
Eligibility | Inclusion Criteria: - American Indians - 15-39 years old - Members of the tribal communities that participate in the Strong Heart Study in southwestern Oklahoma - Only one person per household will be eligible Exclusion Criteria: - Unwilling or unable to follow the intervention, which includes modifying current diet or participating in the proposed physical activity program - Taking lipid-lowering or diabetes medication - Already participating in a diabetes or CVD risk factor reduction program - Are pregnant or plan to become pregnant in the next 18 months. - Underlying disease with an expected life-expectancy of less than 2 years such as cancer or end stage renal disease with dialysis |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Oklahoma | National Heart, Lung, and Blood Institute (NHLBI) |
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* Note: There are 57 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lipid Levels | LDL cholesterol or triglycerides | 9 and 18 months | |
Primary | Glucose Levels | Fasting glucose | 9 and 18 months | |
Primary | Cardiovascular Risk Factor Knowledge | Percentage of correct answers on a knowledge assessment | 9 and 18 months |
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